Despite not being a drug trial, nor a device trial, SafeBoosC III will be conducted in compliance with the guidelines of the Declaration of Helsinki, and of the International Conference on Harmonisation Good Clinical Practice.
Below you will find the central monitoring plan. It has been developed in collaboration with Copenhagen Trial Unit, and central monitoring will be done with them as collaborators.
Central monitoring plan
As stated in the monitoring plan, central monitoring is divided into ‘data completion’ and ‘data quality’ monitoring. Reports on data completion will be conducted on a monthly basis and reports on data quality every third month. All reports will be uploaded to this site and can be found below:
Data completion reports
Below you will find information on local site monitoring, including the monitor plan, and report templates for both initiation- and monitoring visits. All principal investigators must organize Good Clinical Practice monitoring in their own department.